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Myoinositol Effect on Asprosin Levels

Sponsor
Near East University, Turkey (Other)
Overall Status
Completed
CT.gov ID
NCT05943158
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
24.4
Actual Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Asprosin is aa adipokine associated with glucose and insulin metabolism. Insulin and glucose metabolism change during pregnancy and studies examining asprosin levels during pregnancy are increasing rapidly. Considering the beneficial effects of myo-inositol to support the physiological pregnancy, recovering and pre-venting adverse maternal and fetal outcomes, we aimed to evaluate the effects of its supplementation on serum asprosin levels in pregnant women.

Condition or Disease Intervention/Treatment Phase
  • Drug: myoinositol and folic acid
  • Drug: folic acid
 N/A

Detailed Description

Asprosin, which was first mentioned in an article in 2016, is a pluripotent adipokine that is a product of profibrillin and its main source is white adipose tissue. It has been observed that asprosin is associated with glucose metabolism, and its plasma level increases after overnight fasting and decreases after feeding. After the demonstration that asprosin increases glucose secretion from the liver, subsequent studies have determined that its serum levels are increased in type 2 diabetes, human and mouse models with insulin resistance, positively correlates with obesity, and high asprosin levels have been associated with metabolic syndrome.

Pregnancy is known to be a diabetogenic process and insulin resistance is increased during gestation. Also, it is known that there is an increase in the production of adipokines during pregnancy. There are a limited number of studies in pregnancy on asprosin which is known to be produced also from the placenta. Studies examining asprosin in pregnancy in the literature mostly examined the relationship between gestational diabetes (GDM). GDM, which is defined as glucose intolerance with variable severity of hyperglycemia that occurs during pregnancy, is the most common metabolic disorder during pregnancy and its prevalence varies between 5-10% according to the patient population examined and the diagnostic test used. In addition, these patients also have impaired insulin secretion. Recently, it has been shown that asprosin levels are increased in the blood of patients with GDM.

Inositol is a polyol structure molecule belonging to the vitamin B complex, which can be produced in many organs in the body and can also be taken from the outside with food. Myo-inositol (MI) is one of the most important of the 9 inositol stereoisomers, and this molecule has been studied many times in the literature in recent years. In the literature, it is stated that inositol supplementation started in the early weeks of pregnancy prevents GDM onset, especially in women in the risk group for developing GDM like obesity, polycystic ovary syndrome, etc.. MI, which is an intracellular second messenger and has insulin-like effects on glucose metabolism, also reduces insulin resistance.

Based on these data in the literature, it can be thought that altered serum asprosin levels during pregnancy may play a role in the pathogenesis of GDM. In addition, it can be suggested that MI, which have proven effects on glucose metabolism, may have an effect on serum levels of asprosin, which is considered a new insulin resistance marker. In this study, we aimed to examine the effect of the MI on serum asprosin levels of women, which was started in the early stages of pregnancy.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effect of Myoinositol on Serum Asprosin Levels in Pregnant Women
Actual Study Start Date :
Jun 1, 2021
Actual Primary Completion Date :
Jun 30, 2022
Actual Study Completion Date :
Jun 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Myoinositol+folic acid group

This group is given myoinositol+folic acid (inofolic, ITF company, Italy) (myoinositol 4 gram+folic acid 400 micrograms)

Drug: myoinositol and folic acid
The pregnant women were given myoinositol+folic acid starting from initial examination of pregnancy until 24-28 weeks of gestation (time of oral glucose tolerance test)
Other Names:
  • inofolic, ITF company

    		•
    Experimental: Only folic acid group

    This group is given only folic acid once a day (400 micrograms a day)

    Drug: folic acid
    The pregnant women were given only folic acid starting from initial examination of pregnancy until 24-28 weeks of gestation (time of oral glucose tolerance test)
    Other Names:
  • folidoce, ITF company

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Serum asprosin levels [between 5-8 weeks of gestation]

      First measurement of serum asprosin level at initial examination

    2. Serum asprosin levels [between 24-28 weeks of gestation which the oral glucose tolerance test is done]

      Serum asprosin measurement at the time of oral glucose tolerance test

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Healthy pregnant women between 18-40 ages
    Exclusion Criteria:

    • chronic hypertension,

    • pre-pregnancy diabetes or a history of GDM in a previous pregnancy,

    • multiple pregnancy,

    • history of pregnancy-induced hypertension,

    • addiction such as smoking or alcohol,

    • thyroid or other endocrine diseases

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Near East University Faculty of Medicine Nicosia Cyprus 99138

    Sponsors and Collaborators

    • Near East University, Turkey

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ali Cenk, Associate Professor, Cyprus International University
    ClinicalTrials.gov Identifier:
    NCT05943158
    Other Study ID Numbers:
    • Pregnancy ASP
    First Posted:
    Jul 13, 2023
    Last Update Posted:
    Jul 13, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ali Cenk, Associate Professor, Cyprus International University
    pregnancy
    myoinositol
    asprosin
    Additional relevant MeSH terms:
    Marfan Syndrome
    Folic Acid
    Vitamin B Complex
    Inositol

    Study Results

    No Results Posted as of Jul 13, 2023